Pharmaceutical analysis for a patient with rebamipide-induced Stevens-Johnson syndrome by clinical pharmacists / 中国药房

OBJECTIVE To provide reference for the diagnosis and treatment of Stevens-Johnson syndrome caused by rebamipide， and to explore the predisposing factors of Stevens-Johnson syndrome. METHODS Clinical pharmacists analyzed the treatment process of a patient with gastrointestinal diseases and evaluated the correlation between the drug used and adverse reactions， in order to determine the suspected allergenic drug causing Stevens-Johnson syndrome. The predisposing factors of patients with Stevens-Johnson syndrome were explored. RESULTS & CONCLUSIONS The suspected allergenic drugs that caused the patient to develop Stevens-Johnson syndrome included Ilaprazole enteric-coated tablets， Rebamipide tablets and Kangfuxin liquid. In summary， the suspect drug was identified as Rebamipide tablets according to the causality evaluation method of the National Center for Adverse Drug Reaction Monitoring， Naranjo’s scoring method and the algorithm of drug causality for epidermal necrolysis scoring criteria. Hypoproteinemia， competitive binding of plasma proteins between drugs， advanced age， bacterial and viral infections were the predisposing factors of Stevens-Johnson syndrome. Therefore， before using rebamipide in clinical practice， it is necessary to inquire about the patient’s allergy history in detail. During the use process， it is necessary to strengthen the patient’s medication monitoring and be alert to the occurrence of serious adverse reactions. If any abnormalities are found， the medication should be stopped immediately and symptomatic treatment should be given as soon as possible to ensure the safety and effectiveness of the patient’s medication.

Safety and efficacy of the early administration of levosimendan in patients with acute non-ST-segment elevation myocardial infarction and elevated NT-proBNP levels: An Early Management Strategy of Acute Heart Failure (EMS-AHF) / 中华内科杂志

Objectives: To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) and elevated levels of N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) with levosimendan within 24 hours of first medical contact (FMC). Methods: This multicenter, open-label, block-randomized controlled trial (NCT03189901) investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure (EMS-AHF) for patients with NSTEMI and high NT-proBNP levels. This study included 255 patients with NSTEMI and elevated NT-proBNP levels, including 142 males and 113 females with a median age of 65 (58-70) years, and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021. The patients were randomly divided into a levosimendan group (n=129) and a control group (n=126). The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization. The secondary outcome measures included the proportion of patients with more than 30% reduction in NT-proBNP levels from baseline, major adverse cardiovascular events (MACE) during hospitalization and at 6 months after hospitalization, safety during the treatment, and health economics indices. The measurement data parameters between groups were compared using the t-test or the non-parametric test. The count data parameters were compared between groups using the χ² test. Results: On day 3, the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant [866 (455, 1 960) vs. 1 118 (459, 2 417) ng/L, Z=-1.25,P=0.21]. However, on day 5, changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group [67.6% (33.8%,82.5%)vs.54.8% (7.3%,77.9%), Z=-2.14, P=0.03]. There were no significant differences in the proportion of patients with more than 30% reduction in the NT-proBNP levels on day 5 between the levosimendan and the control groups [77.5% (100/129) vs. 69.0% (87/126), χ²=2.34, P=0.13]. Furthermore, incidences of MACE did not show any significant differences between the two groups during hospitalization [4.7% (6/129) vs. 7.1% (9/126), χ²=0.72, P=0.40] and at 6 months [14.7% (19/129) vs. 12.7% (16/126), χ²=0.22, P=0.64]. Four cardiac deaths were reported in the control group during hospitalization [0 (0/129) vs. 3.2% (4/126), P=0.06]. However, 6-month survival rates were comparable between the two groups (log-rank test, P=0.18). Moreover, adverse events or serious adverse events such as shock, ventricular fibrillation, and ventricular tachycardia were not reported in both the groups during levosimendan treatment (days 0-1). The total cost of hospitalization [34 591.00(15 527.46,59 324.80) vs. 37 144.65(16 066.90,63 919.00)yuan, Z=-0.26, P=0.80] and the total length of hospitalization [9 (8, 12) vs. 10 (7, 13) days, Z=0.72, P=0.72] were lower for patients in the levosimendan group compared to those in the control group, but did not show statistically significant differences. Conclusions: Early administration of levosimendan reduced NT-proBNP levels in NSTEMI patients with elevated NT-proBNP and did not increase the total cost and length of hospitalization, but did not significantly improve MACE during hospitalization or at 6 months.

Chemical constituents from fruits of Morinda citrifolia and their inhibitory effects on proliferation of synoviocytes in vitro / 中国中药杂志

The chemical constituents from the fruits of Morinda citrifolia were systematically explored by chromatographic fractionation methods including silica gel, octadecylsilyl(ODS) gel, Sephadex LH-20 gel, and preparative high performance liquid chromatography(pre-HPLC). The chemical structures of all isolated compounds were identified on the basis of their physicochemical properties, spectroscopic analyses, as well as the comparisons of their physicochemical and spectroscopic data with the reported data in literature. As a result, 22 isolated compounds from the 90% ethanol extract of the fruits of M. citrifolia were identified, which were moricitritone(1), 2'-deoxythymidine(2), cyclo-(L-Pro-L-Tyr)(3), methyl-5-hydroxy-2-pyridinecarboxylate(4), methyl pyroglutamate(5), bisbenzopyran(6), epipinoresinol(7), 3, 3'-bisdemethyl pinoresinol(8), 3, 3'-bisdemethyltanegool(9), trimesic acid(10), crypticin B(11), kojic acid(12), vanillic acid(13), protocatechoic acid(14), 5-hydroxymethyl furfural(15), blumenol A(16), 1-O-(9Z, 12Z-octadecadienoyl) glycerol(17), mucic acid dimethylester(18), methyl 2-O-β-D-glucopyranosylbenzoate(19), 2-phenylethyl-O-β-D-glucoside(20), scopoletin(21), and quercetin(22). Among them, compound 1 was a new pyrone derivative, compounds 2, 4-7, 10-12, and 17 were isolated from the plants belonging to Morinda genus for the first time, and compound 18 was obtained from M. citrifolia for the first time. Moreover, on the basis of testing the activities of all isolated compounds on inhibiting the proliferation of synovial fibroblasts in vitro by MTS assay, the anti-rheumatoid arthritis activities of all isolated compounds were initially evaluated. The results showed that compounds 1-6, 9, 19, and 20 exhibited remarkable anti-rheumatoid arthritis activities, which displayed the inhibitory effects on the proliferation of MH7A synovial fibroblast cells with the IC_(50) values in the range of(3.69±0.08) to(168.96±0.98) μmol·L~(-1).

Trauma assessment and first aid in the confined spaces after major natural disasters / 中华危重病急救医学

Major natural disasters seriously threaten human life and health. After earthquakes and other catastrophes, survivors are often trapped in the confined spaces caused by the collapse of ground and buildings, with relative separation from the outside world, restricted access, complex environment, and oncoming or ongoing unsafety, leading to the rescue extremely difficult. In order to save lives and improve the outcome more efficiently in the confined spaces after natural disasters, it is very important to standardize and reasonably apply the trauma assessment and first aid workflow. This study focuses on trauma assessment and first aid. From the aspects of trauma assessment, vital signs stabilization, hemostasis and bandaging, post-trauma anti-infection, and the transportation of patients, a trauma first aid work process suitable for a small space of a major natural disaster is formed, It is helpful to realize the immediate and efficient treatment of trauma in the confined spaces after natural catastrophes, to reduce the rate of death and disability and improve the outcome of patients.

Principles for the rational use of national key monitoring drugs （the second batch） / 中国药房

In order to strengthen the supervision of the use of drugs in hospitals，the Sichuan Academy of Medical Sciences· Sichuan Provincial People’s Hospital took the lead in compiling the Principles for the Rational Use of National Key Monitoring Drugs （the Second Batch） with a number of experts from multiple medical units in accordance with the Second Batch of National Key Monitoring Rational Drug Use List （hereinafter referred to as “the List”） issued by the National Health Commission. According to the method of the WHO Guidelines Development Manual， the writing team used the Delphi method to unify expert opinions by reading and summarizing the domestic and foreign literature evidence of related drugs， and applied the evaluation， formulation and evaluation method of recommendation grading （GRADE） to evaluate the quality of evidence formed， focusing on more than 30 drugs in the List about the evaluation of off-label indications of drugs， key points of rational drug use and key points of pharmaceutical monitoring. It aims to promote the scientific standardization and effective management of clinical medication， further improve the quality of medical services， reduce the risk of adverse drug reactions and drug abuse， promote rational drug use， and improve public health.

Rational use management standards of national key monitoring drug / 中国药房

At present， there is a lack of unified and standardized management for the rational use of national key monitoring drugs. According to the relevant requirements of the state， based on the relevant literature published at home and abroad in recent years and combined with the management practice of many medical institutions across the country on the national key monitoring drugs， in order to make the national key monitoring drugs more reasonable use and standardized management in medical institutions at all levels， the Clinical Pharmacy Branch of the Chinese Medical Association， the Pharmaceutical Epidemiology Special Committee of the Chinese Pharmaceutical Association and the Pharmaceutical Epidemiology Special Committee of the Sichuan Pharmaceutical Association organized experts to fully discuss， and to form this management standard. This standard mainly provides relevant opinions and suggestions on the basic principles of rational use of key monitoring drugs and the regulatory measures for key monitoring drugs， especially on how to strengthen the pharmaceutical management and use management of key monitoring drugs， further promoting the standardized use of key monitoring drugs.

Retrospective Analysis of ADR in Elderly Patients in Sichuan Province during 2013-2019 / 中国药房

OBJECTIVE：To investigate the situ ation and characteristics of ADR reports in the elderly patients （≥65 years old ） of Sichuan province ，and to provide reference for guaranteeing the safety of drug use. METHODS ：ADR reporting data of elderly patients collected by spontaneous reporting system of Sichuan ADR monitoring center from 2013 to 2019 were collected ，and then analyzed in respects of report types ，reproting institution ，relationship，patienst’age，gender，nationality，drug type ，organ/system invovled. RESULTS & CONCLUSIONS ：In the past seven years ，175 431 cases spontaneous ADR were collected by Sichuan ADR monitoring center ，and the annual proportion of “general”ADR reports decreased from 78.93％ in 2013 to 60.50％ year by year ； the annual proportion of “new general ”and“serious”ADRs increased year by year ，among which that of “new general ”ADR increased more obviously. The main reporting institutions were medical institutions ，accounting for 92.79％-98.87％ of the total annual reports. The enthusiasm of enterprises and individuals to report ADR needed to be improved ；8 031 cases（4.58％）were “positive”relationship，21 283 cases（12.13％）were“likely”，146 117 cases（83.29％）were“possible”. Except that the gender of 272 cases were not reported ，there were 88 176 male cases and 86 983 female cases ；most of them were 65-74 years old （104 962 cases，59.83％）. The reports covered 19 nationalities，among which the re were 166 752 cases（98.72％）of Han nationality. The distribution of ADR related drug categories in elderly patients of Yi ， Tibetan and Qiang nationalities was significantly different from that of Han nationality （P＜0.01）. The top three drug categories in the total frequency were anti-infective drugs （31.10％），traditional Chinese medicine com （18.27％），and central nervous system drugs （9.99％）. The injection route was the most likely to cause ADR （72.12％）. ADR mainly involved s kin and its appendants （21.47％）， gastrointestinal system （19.61％）and central and peripheral nervous system （18.55％）. Aminophylline injection was the only dr ug in the top 10 drugs leading to “new general ”ADR for consecutive 7 years. Cefotaxime sodium for injection ，Ceftriaxone sodium for injection ，Cefoperazone sodium and sulbactam sodium for injection were the top 10 drugs causing “severe”ADR in consecutive 7 years，which should be paid more attention in clinic.

Investigation and Analysis of Exposure to Antineoplastic Drugs of Medical Staff in Sichuan Province / 中国药房

OBJECTIVE： To investigation occupational exposure and exposure outcome of antineoplastic in medical staff ，to provide support for their safety in Sichuan Province. METHODS：The respondents included doctors ，nurses，technicians and pharmacists from 11 related departments including tumor department ，hematology department ，PIVAS and pharmacy department in 4 third-level class A hospitals mainly in Sichuan Provincial People ’s Hospital and 6 second-level and below hospitals. Self-designed questionnaires were adopted to investigate general information of medical staff ，cognitive status to occupational exposure hazards ， occupational exposure and exposure outcome and protective behaviors and make suggestions of the investigation. RESULTS：A total of 350 questionnaires were sent out and 304 were recovered ，with effective recovery rate of 86.86％. Among 304 investigated pharmacentical staff ，involving 253 female（83.22％），51 male（16.78％），the most of persons aged 20-29 years old （43.42％）. The most of persons （66.78％）had a bachelor degree. The largest number of occupation was nurses （55.26％）；the pharmacy department had the largest number （21.71％）；working hours were mainly 8 h/day（84.21％）；working years were the most less than 5 years（39.47％）. 121 persons（39.80％）were aware of the potential hazards of occupational exposure to antineoplastic drugs，and 131 persons（43.09％）only knew a little about the Δ 项目基金：国家临床重点专科建设项目；四川省科研院所基本科 exposure hazards ；in PIVAS ，15 persons （71.43％） were 研业务项目（No.2018YSKY0017） ＊药师，硕士研究生。研究方向：临床药学。E-mail：370951417@ aware of the potential hazards of occupational exposure to qq.com antineoplastic drugs ，accounting the highest proportion among # 通信作者：主任药师，硕士生导师。研究方向：国家药物政策、药 all departments ； the proportion of technicians and other 事管理、医院药学。电话：028-87393436。E-mail：289302309@qq.com medical staff who did not know the occupational exposure 中国药房 2020年第31卷第8期 China Pharmacy 2020Vol. 31 No. 8 ·1009· hazard was the highest ，being 60％；the longer the total working time ，the higher the cognition degree of occupational exposure hazards （P＝0.035 8）. The most exposed antineoplastic drug was cyclophosphamide 165 persons（54.28％） and pemetrexed disodium 57 persons（18.75％）was the least. The total time of occupational exposure of medical staff in different departments was mainly short-term exposure ，among which the number of exposed persons in hematology department was the most （85.71％）. 67 persons（22.04％）reported that they had physical discomfort after excluding the influence of other physical diseases ，mainly the increase of alopecia （73.13％）；the propertion of medical staff who had physical discomfort in hematology department was the most（50.00％）；the number of nurses who had physical discomfort （31.55％）was the most. 155 persons（50.99％）could not understand the antineoplastic drug protection measures ，41 persons （13.49％） had received relevant training ，108 persons （35.53％）understood the occupational protection of antineoplastic drugs. The highest level of awareness of protective measures was found among the medical staff in PIVAS ，and only 14.29％ of the staff did not understand the protective measures. In term of occupation，the proportion of nurses who had received relevant training was the highest （19.05％）. CONCLUSIONS ：Medical staffs have a low level of knowledge about occupational exposure hazards and self-protection measures of antineoplastic drugs. The government should strengthen the construction of occupational protection regulations and standards for medical staff ；hospitals should strengthen internal management and attach great importance to the management of occupational protection in hospitals ； medical staff should increase awareness ，skills and reduce the risk of occupational exposure.

Retrospective Analysis of Gestational Adverse Drug Reactions from Sichuan Center for Adverse Drug Reaction Monitoring from Nov. 2016 to Nov. 2017 / 中国药房

OBJECTIVE： To investigate the characteristics and regularity of gestational （including perinatal period） adverse drug reactions （ADR） in Sichuan province， and to provide evidence for ensuring the safety and effectiveness of drug use in clinic. METHODS： Gestational ADR reported to Sichuan provincial ADR monitoring center from Nov. 2016 to Nov. 2017 were statistically analyzed in respects of report source， personnel distribution， general information of patients， route of administration， drug types and main drugs， involved system/organ， grading and outcome， etc. RESULTS： A total of 1 309 gestational ADR cases   （1 340 case time） were collected， in which 1 305 were from medical institutions， 3 from enterprises and 1 from manufacturer. There were 986 physicians， 188 nurses， 133 pharmacists and 2 commissioners for drug safety. 859 cases （65.62％） were 21-30 years old， accounting for the largest proportion. 867 case time were caused by intravenous administration （64.70％）. ADR-inducing drug types mainly included reproductive system drugs （491 case time， 36.64％）， antimicrobial drugs （479 case time， 35.75％） and blood system drugs （110 case time， 8.21％）. Main of them were Carboprost tromethamine injection （187 case time， 13.96％）， Cefazolin sodium for injection （122 case time， 9.10％） and Oxytocin injection （105 case time， 7.84％）. ADR mainly involved skin and its appendants （517 case time， 33.95％）， gastrointestinal system （387 case time， 25.41％）， whole body （175 case time， 11.49％）.  In 1 309 gestational ADR， 1 251 cases （95.57％） were general ADR； 58 cases （4.43％） were severe ADR， including 14 life-threatening cases， 7 extended hospital stay and 37 others； 592 （45.22％） patients improved， 716 （54.70％） recovered and 1 （0.08％） did not improve. CONCLUSIONS： In clinical practice， it is necessary to strengthen the monitoring of drug use in patients during gestational， especially monitor ADR of uterine contraction drugs and antimicrobial drugs during gestational， use drug cautiously and promote clinical medication safety in gestational patients.

Therapeutic Efficacy of Reteplase versus Alteplase in the Treatment of Acute Myocardial Infarction in China ：A Meta-analysis / 中国药房

OBJECTIVE： To evaluate therapeutic efficacy of reteplase versus alteplase in the treatment of acute myocardial infarction in China， and to provide evidence-based reference for clinical treatment. METHODS： Retrieved from Cochrane library， PubMed， Embase， Medline， CJFD， CSJD， Wanfang database by computor， etc.， also by manual search， RCTs about therapeutic efficacy （recanalization rate of thrombolysis） of reteplase （trial group） versus alteplase （control group） in the treatment of acute myocardial infarction in China were collected from Jan. 1995 to Sept. 2018. After data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0， Meta-analysis was performed for recanalization rate of thrombolysis by using Rev Man 5.3 software. RESULTS： A total of 23 RCTs were included， involving 1 742 patients. Results of Meta-analysis showed that recanalization rate of thrombolysis in trial group was significantly higher than control group， with statistical significance [OR＝0.61，95％CI（0.50，0.73），P＜0.001]. Sub-group Meta-analysis was performed according to the successful time of thrombolysis. Results of Meta-analysis showed that recanalization rate of thrombolysis in trial group 1 h [OR＝0.38，95％CI（0.25，0.58），P＜0.001]， 1.5 h [OR＝0.44，95％CI（0.25，0.79），P＝0.006] and 2 h [OR＝0.62，95％CI（0.42，0.92），P＝0.02] after thrombolysis were significantly higher than control group， with statistical significance. CONCLUSIONS： The recanalization rate of thrombolysis by reteplase in Chinese patients with acute myocardial infarction in better than by alteplase.

Comparison of in vitro Percutaneous Permeation Characteristics of Glycyrrhizic Acid in 6 Kinds of Glycyrrhetate Creams / 中国药房

OBJECTIVE:To compare in vitro percutaneous permeation characteristics of glycyrrhizic acid in 6 kinds of glycyrrhetate creams,and to provide reference for further development and utilization. METHODS:Modified Franz diffusion cell and isolated rat skin were adopted for in vitro percutaneous permeation test. 24 h accumulative permeation of glycyrrhizic acid in 6 kinds of glycyrrhetate creams(monoammonium glycyrrhizinate,diammonium glycyrrhizinate,monopotassium glycyrrhizinate, dipotassium glycyrrhizate,trisodium glycyrrhizinate,disodium glycyrrhetate)were determined by HPLC. The permeation characteristics of 6 kinds of glycyrrhetate creams were evaluated by calculating percutaneous absorption rate. RESULTS:24 h accumulative permeation of 6 kinds of glycyrrhetate in rat skin in descending order was as follows:trisodium glycyrrhizinate (23.933 μ g/cm2)>dipotassium glycyrrhizinate(22.952 μ g/cm2)>disodium glycyrrhizinate(15.424 μ g/cm2)>monopotassium glycyrrhizinate(10.703 μg/cm2)>diammonium glycyrrhizinate(9.557 μg/cm2)>monoammonium glycyrrhizinate(1.621 μg/cm2). The percutaneous permeation rate in descending order was as follows as trisodium glycyrrhizinate [1.010 2 μ g/(cm2·h)]>dipotassium glycyrrhizinate [0.974 5 μg/(cm2·h)]>disodium glycyrrhizinate [0.641 2 μg/(cm2·h)]>diammonium glycyrrhizinate [0.399 9 μg/(cm2·h)]>monopotassium glycyrrhizinate[0.362 8 μg/(cm2·h)]>monoammonium glycyrrhizinate[0.072 6 μg/(cm2·h)]. CONCLUSIONS:The permeation rate of trisodium glycyrrhizinate is the highest among 6 kinds of glycyrrhetate creams in vitro.

Comparison of Onxy and N-butyl-2-cyanoacrylate for the embolization of cerebral arteriovenous malformations / 国际脑血管病杂志

Objective To compare the effectiveness and safety of Onyx and n-butyl-2-cyanoacryhte (NBCA) for the embolization of cerebral arteriovenous malformations (AVMs).Methods The clinical data of 53 patients with cerebral AVMs (31 in the NBCA group and 22 in the Onyx group) were analyzed retrospectively.The safety and effectiveness of the 1-year follow-up were compared.The size of AVMs (diameters ＜3 cm,3-6 cm,and ＞6 cm) and the Spetzler-Martin grade were used to conduct subgroup analysis.Results There were no significant differences in the baseline data and AVM morphologies.The embolization rate in the Onyx group was significantly higher than that in the NBCA group (P ＜ 0.05),but there were no significant differences in the incidences of postoperative hemorrhage (1/22 vs.1/31;P=1.000)and neurological deficit (1/22 vs.3/31;P=0.633) in the 1-year follow-up after procedure.The subgroup analysis showed that the embolization rates of the small and medium-sized cerebral AVMs in the Onyx group were significantly higher than those in the NBCA group (all P ＜ 0.05),and the embolization rates of cerebral AVMs with different Spetzler-Martin grades in were significantly higher than those in the NBCA group (all P ＜0.05).Conclusion Onyx is equivalent to NBCA in safety but better in efficacy.

Application Status of Global Trigger Tool / 医药导报

Objective To understand the current application status of global trigger tool ( GTT) in China and abroad, and to provide reference for application and improvement of GTT in medical institutes in China. Methods The databases of Pubmed and CNKI were searched, and the relevant literatures were reviewed and collected, and the application of GTT for measuring adverse events ( AE ) were analyzed and evaluated. Results Fifty-eight valid articles from 15 countries were included.The studies involve several aspects of GTT applications. Articles about GTT used for measuring the incidence of AE accounted for 62.07%, the researches on the object category of AE accounted for 36.21%, those evaluating the effectiveness of GTT as an AE measurement tool accounted for 27.59%, those about improvement and exploration of GTT application performance accounted for 23. 41%, and those about comparison between GTT and other AE detection methods accounted for 15. 52%. In 18.97% of the studies, the number of reviewers and criteria were accordant with the GTT White Paper, but 32.76% of the studies did not clearly describe the reviewers and criteria. The most common method for reporting the AE rate was the proportion of patients with AE.The research object includes 11 categories:common hospital patients, children, patients in intensive care unit ( ICU) , etc.; AE ratio of common hospital patients was 3. 4% to 43. 3%, the preventable proportion was between 32. 2% and 72.4%.The most common types of AE were drug related adverse events, infection/hospital acquired infections, surgery-related complications, abnormal blood potassium, pressure ulcer and so on. Evaluation performed in the United States, Republic ofKorea, Spain, China and other countries and regions' showed GTT had higher efficiency and other advantages as compared with the other AE detection methods including voluntary reporting system, HMPS, QPSIQ DLCR.The exploration of GTT performance improvement involves many factors influencing the detection effectiveness such as different reviewers, review experience, sampling method, sample size, trigger etc. Conclusion GTT has been applied to AE detection of hospital patients in various countries, and it has shown some advantages. GTT is an effective tool for AE measuring, which could be widely used in AE monitoring of hospitalized patients in medical institutions of China.

Application Status of Global Trigger Tool / 医药导报

Objective To understand the current application status of global trigger tool ( GTT) in China and abroad, and to provide reference for application and improvement of GTT in medical institutes in China. Methods The databases of Pubmed and CNKI were searched, and the relevant literatures were reviewed and collected, and the application of GTT for measuring adverse events ( AE ) were analyzed and evaluated. Results Fifty-eight valid articles from 15 countries were included.The studies involve several aspects of GTT applications. Articles about GTT used for measuring the incidence of AE accounted for 62.07%, the researches on the object category of AE accounted for 36.21%, those evaluating the effectiveness of GTT as an AE measurement tool accounted for 27.59%, those about improvement and exploration of GTT application performance accounted for 23. 41%, and those about comparison between GTT and other AE detection methods accounted for 15. 52%. In 18.97% of the studies, the number of reviewers and criteria were accordant with the GTT White Paper, but 32.76% of the studies did not clearly describe the reviewers and criteria. The most common method for reporting the AE rate was the proportion of patients with AE.The research object includes 11 categories:common hospital patients, children, patients in intensive care unit ( ICU) , etc.; AE ratio of common hospital patients was 3. 4% to 43. 3%, the preventable proportion was between 32. 2% and 72.4%.The most common types of AE were drug related adverse events, infection/hospital acquired infections, surgery-related complications, abnormal blood potassium, pressure ulcer and so on. Evaluation performed in the United States, Republic ofKorea, Spain, China and other countries and regions' showed GTT had higher efficiency and other advantages as compared with the other AE detection methods including voluntary reporting system, HMPS, QPSIQ DLCR.The exploration of GTT performance improvement involves many factors influencing the detection effectiveness such as different reviewers, review experience, sampling method, sample size, trigger etc. Conclusion GTT has been applied to AE detection of hospital patients in various countries, and it has shown some advantages. GTT is an effective tool for AE measuring, which could be widely used in AE monitoring of hospitalized patients in medical institutions of China.

A retrospective study of emergency department mortality of a tertiary general hospital from 2004 to 2014 in Shandong province / 中华急诊医学杂志

Objective To determine the trend of emergency department (ED)mortality of a tertiary general hospital from 2004 to 2014 in order to find the factors that may impact on ED mortality.Methods Mortality in ED was estimated according to the ratio of ED visiting patients to ED deaths.And the data of all ED deaths in 2004,2009 and 2014 were collected.Variance analysis and chi-square test were used for data analysis.Results During the past decade,ED visiting patients was increased significantly by 38.0% in 2014,compared with those in 2004,and the mortality was also increased accordingly from 0.7% in 2004, to 0.9% in 2009,to 1.2% in 2014 (P <0.01).Finally,a total of 1,091 deaths occurred in these three years were included for further evaluation.There were no significant changes in average age and gender distribution,and the average age was 61.9 and the male /female ratio was 1.36∶1 during past decade.The number of adults under 40 years old (18 -39)increased from 7.5% in 2004,to 10.6% in 2009,to 14.4% in 2014 (P <0.05).Both the facilities were upgraded and the number of staffs in ED increased markedly.The cardiovascular illness,cerebrovascular diseases,and sudden death were the leading causes of ED death during past decade.The incidences of trauma and tumor remained unchanged.Average time consumed from onset of illness to arrival to ED didn’t vary significantly during past decade.The study showed no changes in use of ambulance,but remarkable increases in number of non-compliant patients or their family from 18.3% in 2004,to 25.6% in 2009,to 38.3% in 2014 (P <0.01).The percentage of patients in the night time was higher,but there were no significant changes in number of emergency patients in the night time and during holidays in the past decade,but the mean ED stay time increased obviously from 22.4 h in 2004 to 53.3 h in 2014 (P <0.05 ).Conclusions During the past decade,although ED facilities and number of staffs have been improved apparently,ED mortality rate still keeps on escalating. The increase in ED mortality rate may be related to the severely ill patients presenting to ED,the obvious decrease in compliance of patients and the prolonged ED stay time.

Determination of Plasma Concentration of Paclitaxel in Tumor Patients by RP-HPLC / 中国药房

OBJECTIVE:To establish a RP-HPLC method to determinate the plasma concentration of paclitaxel in tumor patients.METHODS:Paclitaxel was extracted from plasma with organic phase(ethyl-acetate)by two-step extraction on Tianhe Kromasil C18 column(250 mm?4.6 mm,5 ?m)with a mobile phase consisted of acetonitrile-methanol-water(40∶25∶40)at a flow rate of 1 mL?min-1.The detective wavelength was set at 227 nm and the column temperature was maintained at 35 ℃.RESULTS:The linear range of paclitaxel was 0.05～5.00 mg?L-1(r=0.999 7)with average recovery rate at 98.75%～100.44%.Both intra-day RSD and inter-day RSD were less than 5%(n=5).The plasma concentration-time profile in 11 patients after iv infusion of paclitaxel was in line with a two-compartment model.CONCLUSION:This established method is simple,accurate,reproducible and applicable for clinical determination of blood drug concentration and pharmacokinetic studies.

Determination of Doxorubicin Hydrochloride Concentration in Human Plasma by RP-HPLC / 中国药房

OBJECTIVE:To establish an RP-HPLC method for the determination of doxorubicin hydrochloride concentration in human plasma.METHODS:Tianhe Kromasil C18 was used as column,A solution of methenol-0.01 mol?L-1ammonium dihydrogen phosphate-acetic acid(30200.1) was used as the mobile phase at a flow rate of 1.0 mL?min-1.The detection of wavelength was set at 233 nm.The sample size was 20?L and the column temperature was 35℃.The internal standard was daunorubicin.RESULTS:The calibration curve was linear in the range from 0.25～20.16 ?g?mL-1(r=0.999 6);the average methodological recovery was 96.45%(RSD=2.16%).CONCLUSIONS:The method is rapid,accurate,reproducible and easy to use in clinical detection of blood concentration.